American College Of Surgeons - Inspiring Quality: Highest Standards, Better Outcomes

Playing the Odds - New Drugs, MS, & Prostate Cancer Screening


More than we'd like to admit, decisions about medical treatment require a careful weighing of benefit and risk. Surgery, medication, screening: all come with varying degrees of potential good and potential harm. On today's show: two groups of patients and the decisions they face.

Listen to this episode.

Segment 1: Patients and Drug Safety Reporting
Guest: Dr. Ethan Basch, medical oncologist at Memorial Sloan-Kettering Cancer Center in New York City and author of "The Missing Voice of Patients in Drug Safety Reporting" in The New England Journal of Medicine

New drugs - even those approved by the FDA - come with unknown risks and unknown side effects. Patients who take new drugs share their experience with doctors, and this so-called "post-market" safety reporting gets sent to drug makers and to the FDA. They, in turn, share it with future patients. The system works. But does it really work as well as it should?

A recent article in The New England Journal of Medicine suggests that patient-to doctor-to FDA drug safety reporting has one too many steps. The concern - backed up by research - is that too often doctors underreport the severity of side effects. The solution seems obvious: have patients report their experience directly to the FDA or to drugmakers. But is it that simple?

Segment 2: New Oral Drugs for Treating Multiple Sclerosis
Guest: Dr. Rosalind Kalb
, Vice President of the National MS Society's Professional Resource Center

Few people know better the limits of FDA approval - and the value of postmarket safety reporting - than MS patients. In 2004, when the MS drug Natalizumab (also known as Tysabri) was approved by the FDA, it was the first drug that actually slowed the progress of the disease as opposed to simply managing its symptoms. It was a huge victory for MS patients. But within a year of FDA approval, Tysabri was pulled from the market when it was discovered that the drug was linked to cases of the deadly brain disease PML. When research determined that the risk of PML for patients taking Tysabri was relatively low, the drug's manufacturer Biogen, put it back on the market. Tysabri was effective, patients were told, but came with risks. And now in recent weeks the dangers of the drug have again made headlines as new PML-related deaths have been reported by drugmakers.

But 2010 has given MS patients as much good news as bad. In January, the FDA approved the first drug to improve mobility for MS patients - difficulty walking being a common symptom of the disease. And also in January, The New England Journal of Medicine published the promising results of three large trials of two new medications for treating MS - both of which are taken orally, a welcome alternative to existing MS drugs, which are delivered by injection. And just last week, an FDA panel approved one of those two drugs: Fingolimod or Gilenia, which means that the first drug for treating MS that can be taken orally could be available to patients within the year.

There are 400,000 MS patients currently in the U.S. Two million worldwide. It's a chronic disease with no known cause and no know cure. With MS, like other autoimmune diseases, the immune system mistakenly attacks healthy body tissue - in the case of MS, the brain and spinal cord. People with the disease often suffer muscle spasms, have trouble walking, and experience vision loss, depression, and slurred speech. Women are more likely to be affected than men, and, for reasons unknown to physicians, MS is more likely to occur in patients who live in colder climates.

Earlier this year when The New England Journal of Medicine announced the promising results from two oral MS drug studies, we spoke with Dr. Kalb. She explains the excitement - and the concerns - with the new drugs.

Segment 3: Weighing Risks and Benefits of Prostate Screening
Guest: Dr. Durado Brooks, Director of Prostate and Colorectal Cancer at the American Cancer Society

As MS patients weigh the risks of promising new drugs, men of a certain age are being asked to calculate some risk of their own when it comes to screening for prostate cancer.

"What you don't know could kill you. Get a prostate cancer test. It can save your life."

"Oh ... and happy Father's Day."

If you're a man and you're 50 or older, you've probably heard this message or something like it.

So. Should you get screened for prostate cancer? According to the American Cancer Society: maybe you shouldn't.

Prostate cancer is the second most common cancer in American men and kills 30,000 men every year. But the safety and efficacy of prostate cancer screening has long been debated. Medical organizations make competing - and sometimes conflicting - screening recommendations. Some tell men to skip the test altogether; others recommend taking the test every couple of years.

In a recent revision of their own prostate cancer screening guidelines, the American Cancer Society recommends only that men weigh the risks and benefits of screening ... and then make the decision for themselves. Criticisms of the Society's new guidelines echo the much louder complaints that fueled last fall's angry response to revised mammogram guidelines issued by a government task force. The primary criticism being simply that screening saves lives. The more people that get screened, the argument goes, the fewer people die from cancer.

But prostate cancer screening does come with its share of risks. Dr. Durado Brooks from the American Cancer Society explains.